CAMLOG IMPLANT SYSTEM ABUTMENTS

K073553 · Altatec GmbH · NHA · Mar 5, 2008 · Dental

Device Facts

• Record ID: K073553
• Device Name: CAMLOG IMPLANT SYSTEM ABUTMENTS
• Applicant: Altatec GmbH
• Product Code: NHA · Dental
• Decision Date: Mar 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

Device Story

CAMLOG Implant System Abutments consist of various abutment types (straight crown/bridge, prepable, conical, cast-on, temporary) designed to interface with CAMLOG dental implants. Used by dental professionals in clinical settings to support prosthetic restorations. The abutments serve as the connection component between the endosseous implant and the final crown or bridge prosthesis. They facilitate the fabrication and attachment of dental restorations, enabling functional and aesthetic tooth replacement for patients. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant abutments. Includes straight, prepable, conical, cast-on, and temporary configurations. Mechanical interface designed for compatibility with CAMLOG dental implant systems. Non-software, non-electronic device.

Indications for Use

Indicated for patients requiring dental prostheses (crowns and bridges) supported by CAMLOG dental implants in the maxillary or mandibular arch.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Submission Summary (Full Text)

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# 43553

CAMLOG Implant System Abutments

## 510(k) Summary

# MAR - 5 2008

## Altatec GmbH CAMLOG Implant System Abutments

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Altatec GmbH |
|----------------------------|-------------------------------------------|
| | Maybachstrasse 5 |
| | D-71299 Wimsheim, Germany |
| | Telephone: [phone] |
| | Fax: [phone] |
| Official Contact: | Tina Steffanie-Oak |
| | CAMLOG USA |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| Representative/Consultant: | Linda K. Schulz or |
| | Floyd G. Larson |
| | PaxMed International, LLC |
| | 11234 El Camino Real, Suite 200 |
| | San Diego, CA USA 92130 |
| | Telephone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| | [e-mail] |

### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | CAMLOG Implant System Abutments |
|-----------------------------|------------------------------------|
| Common Name: | Dental implant abutments |
| Classification Regulations: | Endosseous dental implant abutment |
| | 21 CFR 872.3630, Class II |
| Product Codes | NHA |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |

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#### INTENDED USE

CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

#### DEVICE DESCRIPTION

This submission covers a series of abutments for the CAMLOG Implant System, including a straight crown and bridge abutment, a prepable abutment, a conical abutment, a cast-on abutment, and a temporary abutment.

#### EQUIVALENCE TO MARKETED PRODUCT

Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Implant System Abutments are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Altatec GmbH C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

MAR - 5 2008

Re: K073553

Trade/Device Name: CAMLOG Implant System Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 17, 2007 Received: December 18, 2007

Dear Ms. Schulz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Schulz

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any liederal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snytte y. Miakem Oms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### CAMLOG Implant System Abutments

### Indications for Use

510(k) Number (if known):

CAMLOG Implant System Abutments Device Name:

Indications for Use:

CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

Page

510(k) Number:

C673532